drugset / Trial / NCT01674205
Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines
Phase 1
Completed
36 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
University of Rochester · collab
RandomizedParallel-groupTriple-blindBasic science
Summary
This study seeks to understand the host factors that affect the replication and immune response of seasonal and candidate pandemic live attenuated influenza vaccine (LAIV) in humans and to develop biomarkers that can predict the viral shedding and immune response to LAIVs.
Timeline
- Start
- 2012-09
- Primary completion
- 2013-06
- Completion
- 2013-06
Publications
- Background Karron RA, Callahan K, Luke C, Thumar B, McAuliffe J, Schappell E, Joseph T, Coelingh K, Jin H, Kemble G, Murphy BR, Subbarao K. A live attenuated H9N2 influenza vaccine is well tolerated and immunogenic in healthy adults. J Infect Dis. 2009 Mar 1;199(5):711-6. doi: 10.1086/596558.
- Background Belshe RB. Current status of live attenuated influenza virus vaccine in the US. Virus Res. 2004 Jul;103(1-2):177-85. doi: 10.1016/j.virusres.2004.02.031.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | A/swine/Missouri/4296424/2006 (H2N3) x A/Ann Arbor/6/60 ca (H2N3 MO 2006/AA ca) | Vaccine | 0.2 ml | Intranasal |
| Subject | FluMist | Vaccine | — | Intranasal |
| Subject | H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) | Vaccine | 0.5 ml | Intranasal |